Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

The External Partners Delivering The Components Of RNA Therapies

“RNA-based therapeutics” is now a diverse and wide field of application; outsourcing the components of these programs is challenging. Executives at the Society For RNA Therapeutics (SRT) say assembling an entire supply chain can soak up time and resources. Which partners to select depends on what area of RNA development you are pursuing. A fundamental task before all RNA sponsors is thinking deeply in terms of assembling development and manufacturing ecosystems, starting at the earliest stages of research and company formation.

GUEST COLUMNISTS

FDA Issues New Guidance On Therapeutic Equivalence
The FDA has issued a new guidance document, Evaluation of Therapeutic Equivalence, clarifying the scientific and regulatory principles. What does this mean for drug developers and manufacturers?
July 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
ADC CDMO Selection For Small Biotech
Manufacturing is a critical factor in ADC success. Discover how to align CDMO capabilities with molecule complexity, mitigate risks, and navigate capacity limits.
Europe's ATMP Opportunity Still Requires Local Navigation
European nations offer a welcoming environment for clinical-phase cell and gene therapies. Don't assume the same flexibility carries through to commercialization.
The Unspoken Truth About Cell Therapy Product Understanding
Developers often discover important attributes after it's too late to act on them. A well-designed program asks what's needed for commercialization and works backward.
Implementing And Optimizing Your eQMS
This article addresses everything that follows the signed contract for an eQMS: how a system is configured, validated, adopted, and maintained.
Rebuilding America's Pharmaceutical Backbone Through Small-Batch Manufacturing
Many small molecule products no longer require massive production. Instead, flexible capacity is needed that can economically produce smaller commercial volumes while maintaining quality and compliance.
CDMO Selection For Small Biotech: Amit Jain On Avoiding Costly Transfers
Make smarter outsourcing decisions early. Reduce the risk of costly tech transfers, evaluate capacity needs, speed development timelines, and strengthen manufacturing partnerships.

PHARMA OUTSOURCING WHITE PAPERS

The Role Of A Consulting Firm In The IND Process
Navigate the complex IND process with expert guidance and discover how early FDA engagement can accelerate your path to clinical trials.

Redefining OSD Development Through Foresight And Innovation
From early formulation challenges to scale-up and commercial readiness, proactive planning and integrated capabilities help teams anticipate risks, accelerate decision-making, and maintain momentum across development.
Onshoring Advantage: 7 Forces Reshaping Global Biologics Manufacturing
Policy, trade, and security pressures are fundamentally reshaping global biologics manufacturing. Forward-looking companies are onshoring critical programs to mitigate risks to supply chains, IP, and regulatory timelines.
Pharmaceutical Spray Drying – Technology And Applications
Explore the transformative potential of pharmaceutical spray drying in improving drug formulation, bioavailability, and delivery through versatile and innovative applications.
A Shift Towards Biofluorescent Particle Counters In Manufacturing
Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.
Redefining Biomanufacturing For Personalized Cancer Vaccines
Personalized cancer vaccines need fast, flexible manufacturing. Cell‑free synthetic DNA enables rapid, small‑batch mRNA production, supporting individualized therapies beyond plasmid‑based limits.